Comparative study of promoted generic substitution policies in China, USA and Japan based on full cycle management

Corresponding author: SHAO Rong, shaorong118@163.com

DOI: 10.12201/bmr.202305.00004

•  

  Abstract: Objective:Based on the concept of full cycle management, multiple links from the registration of generic drug R D, market access, clinical use, and postmarketing reevaluation will provide recommendations for the development and improvement of the policy on the promotion of generic drug substitution in China. Methods: Using a policy research approach and a literature research approach, we conducted a comparative analysis of the current state of policy on the promotion of generic drug substitution between China and Japan. Conclusions: Generic drug substitution is a systematic engineering involving multiple links, and the United States and Japan have addressed this topic by continually refining technical standards and data guidelines in the R D registration link, reasonably pricing and Medicare incentives in the market access link, managing physician pharmacist prescribing behavior in the clinical use link, enhancing advocacy Education, and reevaluating and evaluating alternative effects of generic drugs in the postmarketing reevaluation link, A full cycle policy system of generic drug substitution promotion was constructed and the objectives of generic drug substitution were achieved.

  Key words: Generic substitution; Medicare payment; Consistency evaluation of generic drugs

  Submit time: 9 May 2023

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
• html

• 图表

• HAN You-li, CUI Ji-yu. Research on the development strategies of new antineoplastic agents: An analysis based on the comparison of new drugs launched in China, America and Japan. 2021. doi: 10.12201/bmr.202106.00021

  MENG wen-xin, JIANG Rong. Comparison study of dual channel management policies of nationally negotiated drugs in Jiangsu province. 2022. doi: 10.12201/bmr.202209.00002

  YANG Ci-ran, WANG Rui, LUO Yin, AN Shu-han, WU Yu-xin, MAO Zong-fu, CUI Dan. Policy design of “Dual-channel” management for national negotiated drugs: A inter-provincial comparative analysis. 2023. doi: 10.12201/bmr.202305.00006

  SUN Wenjun, ZHAO Ziyin, CHENG Zheyu, LI Huining, ZHU He. Impact of the national centralized drug procurement policy on drug prices and utilization: a systematic review. 2023. doi: 10.12201/bmr.202303.00033

  YU Miao, SONG Qi, YANG Yansui, TUO Hongwu. Analysis of the Effect of Traditional Chinese Medicine Medical Insurance Payment by the Diagnosis-Intervention Packet: Based on the Medical Insurance Reform Practice in Liuzhou. 2023. doi: 10.12201/bmr.202306.00002

  HAN Meng, WANG Shi-jia, HU Hao-yu, ZHAO Yan-jiao, CHEN Yong-fa. Comparative Study on Grouping Rules in Centralized Volume-based Procurement of Chinese Patent Medicine. 2023. doi: 10.12201/bmr.202312.00008

  ZhangJinsui, Humin, ChenWen, GongYichun, LI Jian-mei. Exploration and enlightenment of the content design of credit management for the basic medical insurance participants in China——Based on the content analysis of the text of credit management policy of 18 regions. 2022. doi: 10.12201/bmr.202207.00025

  Rong Hongguo, XING Ye-yiyi, dong yue, xia ruyu, SHANG Hong-cai, Liu jianping, FEI Yu-tong. Analysis of rational use of antibacterial drugs policies based on the perspective of policy tools. 2021. doi: 10.12201/bmr.202107.00021

  JiangMingzhu, Ying Xiaohua. Quantitative research of vaccine management policy in China - Text analysis based on policy instruments, policy subjects and policy points. 2022. doi: 10.12201/bmr.202212.00005

  xuguangjian, qiaoyukun. Research on the linkage mechanism between the adjustment of medical service price and the reform of medical insurance payment mode in China. 2021. doi: 10.12201/bmr.202104.00018

• ID	Submit time	Number	Download
  1	2022-11-09	bmr.202305.00004V1	Download

• Public  Anonymous  To author only Submit Comments